MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X14MM CORT LOCK SCR STE; PLATE, FIXATION

Model Number	8561-35-014
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign- (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported during the inspection that there was debris in the sterile package.No adverse event has been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d9; g3; g6; h1; h2; h3; h6 visual examination of the returned product/provided pictures found a piece of unknown debris within the sterile area.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The root cause of the reported event is the operator not following the work instructions provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 3.5X14MM CORT LOCK SCR STE
• Common Device Name: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11633512
• Report Number: 0001825034-2021-00922
• Device Sequence Number: 3843564
• Product Code: HRS
• UDI-Device Identifier: 00887868351822
• UDI-Public: (01)00887868351822(17)301012(10)036010
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8561-35-014
• Device Catalogue Number: 856135014
• Device Lot Number: 036010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1